Description
Mycophenolate injection belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines (eg, cyclosporine, steroid medicine) to lower the body's natural immunity in patients who receive organ transplants (eg, kidney, heart, or liver).
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate injection prevents the white blood cells from rejecting the transplanted organ.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.
Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate injection in children receiving heart or liver transplants. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate injection.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acyclovir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Amoxicillin
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Cholestyramine
- Ciprofloxacin
- Clavulanic Acid
- Colesevelam
- Colestilan
- Colestipol
- Cyclosporine
- Dengue Tetravalent Vaccine, Live
- Desogestrel
- Dexlansoprazole
- Dienogest
- Drospirenone
- Ebola Zaire Vaccine, Live
- Esomeprazole
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Ferric Citrate
- Ganciclovir
- Gestodene
- Influenza Virus Vaccine, Live
- Isavuconazonium Sulfate
- Lansoprazole
- Lanthanum Carbonate
- Levonorgestrel
- Measles Virus Vaccine, Live
- Mestranol
- Metronidazole
- Mumps Virus Vaccine, Live
- Nomegestrol
- Norethindrone
- Norfloxacin
- Norgestimate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bone marrow problems (eg, neutropenia) or
- Hepatitis B or C infection or
- Stomach or bowel problems (eg, ulcers, bleeding)—Use with caution. May make these conditions worse.
- Infection (eg, bacteria, fungus, or virus), active—May decrease your body's ability to fight an infection.
- Kelley-Seegmiller syndrome (rare genetic disease) or
- Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any questions about this, talk to your doctor.
Precautions
It is very important that your doctor check your progress while you are receiving this medicine. Your doctor will do blood tests to make sure that mycophenolate injection is working properly and to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby or cause a miscarriage during the first 3 months. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, including a condom, diaphragm, or contraceptive foam or jelly. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not donate sperm during treatment and for at least 90 days after the last dose.
Mycophenolate injection can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
This medicine may increase your risk of developing rare and serious virus infections, including shingles, herpes, cytomegalovirus (CMV) infection, polyomavirus associated nephropathy (PVAN), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble with breathing, unusual tiredness or weakness, vomiting, or weight gain.
This medicine may cause reactivation of hepatitis B or C infection. Check with your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
Check with your doctor right away if you have difficulty in moving, fever, muscle pain or stiffness, or pain, swelling, or redness in the joints. These may be symptoms of acute inflammatory (swelling) syndrome.
While you are receiving mycophenolate injection, and after you stop, do not have any immunizations (vaccines) without your doctor's approval. Mycophenolate injection will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.
Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.
This medicine may cause serious stomach or bowel problems (eg, ulcers, bleeding). Check with your doctor right away if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, or burning, trouble breathing, or vomiting of blood or material that looks like coffee grounds.
Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Blood in the urine
- chest pain or discomfort
- cough or hoarseness
- difficulty in moving
- fever or chills
- increased cough
- loss of strength or energy
- lower back or side pain
- muscle pain, cramps, stiffness, or weakness
- pain in the joints
- painful or difficult urination
- swelling of the feet or lower legs
- trouble breathing
Less common
- Black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at injection site
- bloody vomit
- enlarged gums
- irregular heartbeat
- joint pain
- pinpoint red spots on the skin
- red, inflamed, or bleeding gums
- sores inside the mouth
- stomach pain
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- white patches on the mouth, tongue, or throat
Incidence not known
- Back pain
- bloody, black, tarry stools
- blue lips, fingernails, or skin
- blurred vision
- chronic or occasional diarrhea
- clumsiness
- confusion
- coughing or spitting up blood
- difficulty speaking or understanding what others say
- dizziness
- drowsiness
- general feeling of illness or nausea
- headache
- heart murmur
- irregular, fast or slow, or shallow breathing
- loss of coordination
- memory loss
- night sweats
- seizures
- severe headache
- sore throat
- stiff neck or back
- stomach distention
- stools that float, are foul smelling, or "fatty"
- sudden high fever or low-grade fever for months
- unusual tiredness or weakness
- vision changes
- weakness in the legs
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
- diarrhea
- heartburn
- nausea
- vomiting
- weakness
Less common
- Acne
- skin rash
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20068185
